Hello,
Someone have an idea if the FDA have any requirement or guideline refered to alert level of humidity in cleanroom ISO 7 or ISO 8 ?:confused:
thanks for your replies

Hello,
Someone have an idea if the FDA have any requirement or guideline refered to alert level of humidity in cleanroom ISO 7 or ISO 8 ?:confused:
thanks for your replies

There is a mention about Humidity in ISO 14644.

Humidity control is primarily for -

1. Manufacturing process
2. Personnel comfort, and
3. Reduction of electro static charges

A typical range is defined as < 65 % RH to > 30 % RH.

Hello,
Someone have an idea if the FDA have any requirement or guideline refered to alert level of humidity in cleanroom ISO 7 or ISO 8 ?:confused:
thanks for your replies

From the FDA - US Food & Drug Admin site http://www.fda.gov/CDRH/qsr/06bldng.html

"No FDA guidances for these parameters presently exist for environmentally controlled areas such as clean rooms."

Here is a list of typical clean room conditions listed on their site.

Particulates: Maximum of 10,000 of 0.5 micron diameter or larger per cf
Humidity: 45 +/* 5 percent
Temperature: 72 +/* 2.5 degrees F
Air Velocity: 90 feet/minute +/* 2 percent
Air Pressure: 0.05 inches water between the clean room and other areas

Dave

Thanks for your replies,
However this is guidelines for class 100 ISO 5, generaly we as cleanroom designer we estimate ( if the process is not required any special conditions) an alarm level of 60% humidity. But in our country where the external conditions are very extrem in such summer days, even this level alarm is tough to achieved ? Even with a special HVAC Makeup air AHU that treat all the makeup air and then delivery the treated air to the local HVAC AHU that take care of the cleanroom thermic load. What it will be the best level of alarm to be setup before lauched an deviation process and CAPA ?
Thanks for you suggestions.
ERIC

Thanks for your replies,
However this is guidelines for class 100 ISO 5, generaly we as cleanroom designer we estimate ( if the process is not required any special conditions) an alarm level of 60% humidity. But in our country where the external conditions are very extrem in such summer days, even this level alarm is tough to achieved ? Even with a special HVAC Makeup air AHU that treat all the makeup air and then delivery the treated air to the local HVAC AHU that take care of the cleanroom thermic load. What it will be the best level of alarm to be setup before lauched an deviation process and CAPA ?
Thanks for you suggestions.
ERIC

During validation of the cleanroom you should correlate between bioburden on the produced items and the conditions in the room; temperature, humidity etc. You can then establish a documented threshold for your conditions. That is - IMO - the reason that "No FDA guidances for these parameters presently exist for environmentally controlled areas such as clean rooms."

As with all validation, what works for you, and what you can document, is the thing that you do.

:bigwave:

During validation of the cleanroom you should correlate between bioburden on the produced items and the conditions in the room; temperature, humidity etc. You can then establish a documented threshold for your conditions. That is - IMO - the reason that "No FDA guidances for these parameters presently exist for environmentally controlled areas such as clean rooms."

As with all validation, what works for you, and what you can document, is the thing that you do.

:bigwave:


Spot on. Good post. :agree1:

Dave